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Erector Spinae Plane Block in Cardiac Surgery

Primary Purpose

Pain, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
opioid analgesia
ESP block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Acute

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective surgery

Exclusion Criteria:

  • emergency
  • patient refusal
  • infection at or near catheter insertion

Sites / Locations

  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

group B

Arm Description

opioid analgesia

ESP block

Outcomes

Primary Outcome Measures

pain score
NRS will be used to assess pain

Secondary Outcome Measures

anaesthesia consumption
cumulative anaesthesia MAC
ultrasound guided postoperative diaphragmatic excursion
diaphragmatic movement during inspiration an expiration
spirometric respiratory funtion

Full Information

First Posted
February 20, 2019
Last Updated
June 22, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03997019
Brief Title
Erector Spinae Plane Block in Cardiac Surgery
Official Title
Ultrasound Guided Erector Spinae Plane Block in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A WILL RECEIVE OPOID analgesia group B will receive ESP block
Masking
ParticipantOutcomes Assessor
Masking Description
both patient and data collector will be unaware of the group nature
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
opioid analgesia
Arm Title
group B
Arm Type
Active Comparator
Arm Description
ESP block
Intervention Type
Procedure
Intervention Name(s)
opioid analgesia
Intervention Description
opioid analgesia will be used with general anaesthesia
Intervention Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
ultrasound guided ESP Block before anaesthesia induction
Primary Outcome Measure Information:
Title
pain score
Description
NRS will be used to assess pain
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
anaesthesia consumption
Description
cumulative anaesthesia MAC
Time Frame
6 hours
Title
ultrasound guided postoperative diaphragmatic excursion
Description
diaphragmatic movement during inspiration an expiration
Time Frame
24 hours
Title
spirometric respiratory funtion
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elective surgery Exclusion Criteria: emergency patient refusal infection at or near catheter insertion
Facility Information:
Facility Name
Faculty of Medicine
City
Asyut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rasha hamed
Phone
01000440773
Email
rashaahmed11@yahoo.com
First Name & Middle Initial & Last Name & Degree
saeed elsawy
Phone
01030072161
Email
saeedelsawy17@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Erector Spinae Plane Block in Cardiac Surgery

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